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Behavioural Intervention

Telerehabilitation for Parkinson's Disease (PKT Trial)

N/A

Recruiting

Led By Livia Pinheiro Carvalho, PhD

Research Sponsored by Université de Sherbrooke

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Patients having cardiovascular dysautonomia according to the clinical criteria: supine hypertension (SH) (≥140/90 mmHg) and/or orthostatic hypotension (OH) (a drop of systolic blood pressure ≥ 20 mmHg and/or diastolic blood pressure ≥ 10 mmHg during the active orthostatic hypotension test)

50 years or older

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 12 weeks

Awards & highlights

PKT Trial Summary

This trial aims to improve the lives of people with Parkinson's Disease by researching and providing a hybrid telerehabilitation program to target cardiovascular health.

Who is the study for?

This trial is for people over 50 with Parkinson's Disease who have stable medication and internet access. They must speak French or English, and have cardiovascular dysautonomia (blood pressure issues when standing up or lying down). It's not for those with major cognitive impairments, other neurological disorders, physical conditions preventing exercise, contraindications to physical activity, or a cardiac pacemaker.Check my eligibility

What is being tested?

The study tests a hybrid telerehabilitation program aimed at improving cardiovascular health in Parkinson's patients. It will evaluate how feasible and effective this online/offline approach is in managing symptoms related to the autonomic nervous system.See study design

What are the potential side effects?

Since the intervention involves non-drug rehabilitation exercises conducted remotely, side effects are minimal but may include discomfort from physical activities or technical difficulties with the telehealth platform.

PKT Trial Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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I have been diagnosed with cardiovascular dysautonomia, experiencing significant blood pressure changes when standing.

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I am 50 years old or older.

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My Parkinson's disease is in the early to mid-stage.

PKT Trial Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 12 weeks

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~12 weeks

This trial's timeline: 3 weeks for screening, Varies for treatment, and 12 weeks for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

Acceptability

Dysautonomia Symptoms

Exercise capacity

+3 more

Secondary outcome measures

Autonomic modulation

Balance

Cardiovascular health

+10 more

PKT Trial Design

1Treatment groups

Experimental Treatment

Group I: Intervention groupExperimental Treatment1 Intervention

Group of participants receiving the hybrid telerehabilitation intervention

0 / 3Eligibility criteria met

Find a Location

Who is running the clinical trial?

Centre de Recherche sur le Vieillissement (CdRV)UNKNOWN

Université de SherbrookeLead Sponsor

292 Previous Clinical Trials

69,425 Total Patients Enrolled

Livia Pinheiro Carvalho, PhDPrincipal InvestigatorUniversité de Sherbrooke

1 Previous Clinical Trials

7 Total Patients Enrolled

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

What is the cap on participants for this research endeavor?

"Affirmative. Clinicaltrials.gov verifies that this study is actively searching for participants, beginning on June 13th 2023 and updated most recently as of August 23rd 2023. 16 people are required to participate from a single medical site in order to reach the desired sample size."

Answered by AI

Is the enrollment process open for this clinical investigation?

"Indeed, the details accessible on clinicaltrials.gov indicate that this trial is actively recruiting from a single location and is searching for 16 participants in total. The data was first posted on June 13th 2023, with the latest update occurring on August 23rd of the same year."

Answered by AI

What outcomes is this medical experiment hoping to yield?

"The primary metric this trial is basing its findings on over the 12 week period of evaluation is Fidelity. Secondary measurements include an assessment of Neuropathic pain DN4 Questionnaire (0-10 points), Perceived quality of life based upon Parkinson's disease Questionnaire 8 items (PDQ-8, 0-32 points), and Lower Extremity Functional Scale for lower limb function tracking (LEFS, 0-32 higher scores indicating less difficulty)."

Answered by AI

Recent research and studies

clinicaltrials.govStudy

Telerehabilitation for Dysautonomia in Parkinson's Disease

2023. "Telerehabilitation for Dysautonomia in Parkinson's Disease". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT06017232.